NCT00024284

Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors

A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and irinotecan in treating children who have refractory solid tumors.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose and recommended phase II dose of carboplatin and irinotecan in children with refractory solid tumors. * Determine the safety profile and dose-limiting toxic effects of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. * Determine the preliminary anti-tumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study of carboplatin and irinotecan. Patients receive carboplatin IV over 50 minutes on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for at least 30 days. PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study within 6-9 months.

Conditions

• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	irinotecan hydrochloride

Timeline

• Start date: 2001-06-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2003-01-27
• Last updated: 2013-04-05

Locations

7 sites across 2 countries: United States, Canada